Director / Senior Director, Quality

About This Role

Directing and leading the quality system for a clinical-stage biotechnology company is the core of this role, as the company moves into Phase 2. The successful candidate will build and own the GxP quality system, covering clinical quality (GCP) and CMC quality (GMP) end to end, including procedure lifecycle, quality management system administration, vendor qualification and oversight, training, audits, and inspection readiness. This position suits a hands-on, execution-focused quality leader who can right-size the system for a fifty-person company.

Responsibilities

• Own the clinical quality management system end to end: document control, procedure lifecycle, training, deviations, CAPA, quality issue escalation, and periodic review
• Maintain the procedure set at a size and shape the company can comply with
• Author, revise, consolidate, and retire SOPs through controlled document lifecycle, with documented rationale, process-owner agreement, and quality approval
• Serve as Qualio administrator and process owner: configuration, workflows, document control, training curricula and assignment, periodic review cycles, change control, and reporting
• Establish and implement a fit-for-purpose, risk-based GxP vendor qualification and oversight framework, including tiered qualification criteria, initial and periodic re-qualification assessments, and ongoing performance monitoring
• Own qualification records and quality agreements end to end, ensuring each clearly defines quality roles, responsibilities, and escalation pathways between the company and the vendor
• Apply risk-based quality management: identify critical-to-quality factors, document quality risk assessments per protocol, and direct oversight to where risk to patients and data integrity actually sits
• Own GCP and role-based training across the company: curricula, assignment, completion, and competency tracking
• Manage sponsor audits and regulatory inspections and drive responses and CAPA to closure
• Oversee vendor quality event reporting and trending across the vendor network: define reporting requirements and timelines in quality agreements, track and trend events by vendor and category, roll up global metrics for leadership visibility, and ensure vendor-originated events feed into the CAPA system with clear ownership and closure tracking
• Run a risk-scoped audit program covering vendors, investigator sites, and internal processes
• Serve as the quality interface with functional owners (Clinical Operations, Regulatory, CMC/Biometrics, etc.) and the go-to GCP subject matter expert on protocol design, study conduct, and regulatory expectations
• Proactively surface quality risks and trends to functional and senior leadership, and partner cross-functionally to embed quality considerations into study planning and decisions
• Own the GMP quality system and keep it within the same Qualio instance, ensuring document control, deviations, change control, CAPA, and training under common governance